Company: Baxter Healthcare CorpDate of Enforcement Report: 8/14/02 Class: I PRODUCT Logix-CM Compounder Software. Recall # Z-1203-2. REASON Software allows ingredient concentration errors during compounding. CODE Catalog #2M8400, Logix-CM software version 1.0.2. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL, by telephone on June 18, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company: Siemens Medical Solutions USADate of Enforcemet Report: 8/14/02 Class: I PRODUCT e.soft software version 2.0 used on all E.CAM Emission Imaging Computed Tomography Systems with e.soft A or e.soft A/P nuclear medicine workstations. Recall # Z-1189-2. REASON Incorrect image time stored for static images resulting in incorrect results. CODE e.soft software version 2.0 installed...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 8/7/02 Class: II PRODUCT 1.5T MR Systems with software version R7.1.2 and higher: Magnetic Resonance Systems are indicated for use as diagnostic devices that produce transverse, sagital, coronal and oblique cross-sectional images, spectroscopic images and/or spectra based upon 1H and 31P metabolites, and that display the internal structure...Read More

Company: Baxter Healthcare CorpDate of Enforcement Report: 7/31/02 Class: II PRODUCT Baxter Ipump Pain Management System infusion pump, product codes 2L3107 and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1166-2. REASON Software anomaly allows access to change prescription or program bolus without security. CODE Product codes 2L3107 and 2L3107R, all serial numbers. RECALLING FIRM/MANUFACTURER...Read More

Company: Semens Medical SystemsDate of Enforcement Report: 7/31/02 Class: II PRODUCT SONOLINE Antares, Diagnostic Ultrasound System. The SONOLINE Antares is a high-resolution, digital, broadband diagnostic ultrasound imaging system. It supports the following diagnostic applications: abdominal, OB/GYN, small parts, musculoskeletal, vascular, and urology. Recall # Z-1162-2. REASON Software anomalies that affect measurement and calculation data. CODE...Read More

Company: Philips Medical Systems Date of Enforcement Report: 7/31/02 Class: II PRODUCT Intera 1.0T and 1.5T MR Systems Magnetic Resonance Systems are indicated for use as diagnostic devices that display the internal structure and/or function of the head, body or extremeties. The coils are used to obtain optimal imaging. Recall # Z-1147-2/Z-1148-2. REASON Higher than...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 7/3/2002 Class: II PRODUCT Information Center System and Upgrades as follows: a) M3150A Agilent or Virida Information center. Recall # Z-1119-2; b) M3151A Agilent or Virida Information Center Client. Recall # Z-1120-2; c) M3153A Agilent or Virida Surveillance Center. Recall # Z-1121-2; d) M3150AU#A01 Agilent or Virida Information...Read More

Company: Varian Medical Systems, Inc Date of Enforcement Report: 7/3/2002 Class: II PRODUCT Varian Medical System’s Eclipse VERSION 6.5 software, a proprietary application for Varian Vision ™ imaging systems. Recall # Z-1109-2. REASON Radiation treatment planning software malfunction could result in incorrect treatment regimen. CODE Eclipse software, version 6.5, Serial Numbers: 0016 0018 0022 0034...Read More

Company: Toshiba America Medical Systems, IncDate of Enforcement Report: 6/26/02 Class: II PRODUCT NEMIO, SSA550A, Diagnostic Ultrasound System. Recall # Z-0923-2. REASON Software anomally caused error in calculating VM_P. CODE Serial Numbers: B1552349 C1572413 C1572414 C1572415 C1572417 C1572418 C1572420 C1572423 C1572428 C1572429 C1572430 C1572431 C1572432 C1572433 C1572421. RECALLING FIRM/MANUFACTURER Toshiba America Medical Systems, Inc., Tustin,...Read More

Company: Advanced Sterilization ProductsDate: 6/19/2002 Class: II PRODUCT STERRAD 100S Sterilization System. Recall # Z-1082-2. REASON Software anomaly allows half cycle run when full cycle displayed. CODE Version 3 or lower is subject to upgrade. Newer versions contain software “fix”. Current version is Version 6. RECALLING FIRM/MANUFACTURER Advanced Sterilization Products, Irvine, CA, by letters sent...Read More

Company: Liebel-Flarsheim CoDate of Enforcement Report: 5/29/2002 Class: II PRODUCT Liebel-Flarsheim Angiomat Illumena Media Power Injectors, P/N 900001, using Version 8.0 software with new console. Recall # Z-1046-2. REASON Pushing the scoll button repeatedly / rapidly results in erroneous protocol ID. CODE Serial Numbers: 0202-5000 to 0402-5126. RECALLING FIRM/MANUFACTURER Recalling Firm: Mallinckrodt, Inc. / Liebel-Flarsheim...Read More

Company: Fujifilm Medical Systems U.S.ADate of Enforcement Report: 5/29/02 Class: II PRODUCT Synapse Image and Information Management System. Recall # Z-1045-2. REASON Rotated/flipped Images not viewed on the screen may not rotate but left / right markers will be flipped. CODE Synapse Image and Information Management System with software versions 2.0.2 and 2.1.1. RECALLING FIRM/MANUFACTURER...Read More

Company: Sigma International MedinaDate of Enforcement Report: 5/8/02 Class: II PRODUCT Sigma 8000 Volumetric Infusion Pumps with software version 3.50.01. Recall # Z-0991-2. REASON Software error: Distal occlusions may not be detected (no alarm) at rates above 550 ml/hr. CODE The following serial numbers. 49105, 49111R, 49188R, 49288R, 49289R, 49402R, 49436R, 49448R, 49454R, 49466R, 49507R,...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 5/1/2002 Class: III PRODUCT Integris H5000, Angiographic X-ray system. Recall # Z-0924-2. REASON System may occasionally re-boot during a patient examination. CODE Units with SYSCO software version 11.1.2. RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated November 14, 2001., Manufacturer: Philips...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 5/1/02 Class: II PRODUCT All DataCare Systems Software, as follows: Recall # Z-0960-2/Z-0974-2. a) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200; b) DataCare ABG Data Management System for use in a blood gas point of care testing...Read More

Company: Hitachi LtdDate of Enforcement Report: 5/1/02 Class: II PRODUCT Roche Modular Analytics immunoassay based clinical chemistry analyzer, model E170, catalog number 7656961. Recall # Z-0922-2. REASON Possibility of false negative and false positive results being reported. CODE All units with software version 01-03. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter...Read More

Company: Sunquest Information systems, aka Misys HealthcareDate of Enforcement Report: 5/1/02 Class: II PRODUCT Misys Laboratory Microbiology Module, Recall # Z-0916-2. REASON Software does not allow comments to be shown in some reports. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information systems, aka Misys Healthcare, Tucson, AZ. Firm initiated recall is ongoing. VOLUME...Read More

Company: Sunquest Information Systems, IncDate of Enforcement Report: 4/24/02 Class: II PRODUCT Misys Laboratory for Windows version 5.3. Recall # Z-0888-2. CODE REASON Software QA code of BOTH for patient sex can result in QA flags not being generated for abnormal results. Versions 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., aka Misys Healthcare Systems Tucson,...Read More

Company: Zoll Medical CorpDate of Enforcement Report: 4/24/02 Class: I PRODUCT a) Zoll M Series Advisory Defibrillator. Recall # Z-0893-2; b) Zoll M Series AED Defibrillator (semi automatic defibrillator). Recall # Z-0894-2. REASON Defibrillator may fail to detect ventricular fibrillation and fail to deliver shock. CODE a) Serial Numbers: T98F00046-T01K27762 with System Software Version below...Read More

Class: III Aeroset Chloestorol Reagent Lot 82099HW00. Firm’s list no. 7D62-01. Manufacturer: Abbott Laboratories, Inc., Sout Pasadena, CA Recalled by: Manufacturer, by letters on April 17, 2002. Firm initiated recall is ongoing Distribution: Nationwide and internatinally; 715 units were distributed Reason: Stability may be compromised over time, product currently OK Recall number: Z-1031-2Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 4/17/02 Class: II PRODUCT Misys Laboratory (formerly FlexiLab) information system. Recall # Z-0803-2. REASON Software anomaly may allow patient results to be transposed against another patient header or identification. CODE Versions 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tuscon, AZ, by notice on March 8, 2002....Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 4/10/02 Class: II PRODUCT All DataCare Systems Software, as follows: a) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200 b) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9201...Read More

Company: Sunquest Information Systems, IncDate of Enforcement Report: 4/10/02 Class: II PRODUCT FlexiLab Laboratory Information System. Recall # Z-0710-2. REASON Date Format Issue–Flexilab Software converts specimen collect and receipt dates to American standard format ‘mm/dd/yyyy’. For sites using the Euro date format this can alter the generation of QA warnings or flags based on collect...Read More

Company: Siemens AG Medical EngineeringDate of Enforcement Report: 3/27/02 Class: III PRODUCT a) ACOM.PC Angiographic X-ray System; b) Digital Image Communications System. Recall # Z-0603-2. REASON Software problem in recording heights and weights. CODE Siemens part number: a) ACOM.PC V3.0-4371105 b) Quantcor V4.0-4786898, 5915553, 5915579. Equipment Concerned: Product: Part No. Serial No. LVA V 4.0...Read More

Company: Bayer CorporationDate of Enforcement Report: 3/27/02 Class: III PRODUCT Clinitek 100 Software Kit. Recall # Z-0634-2. REASON False negative results when high concentrations of ketone exist. CODE Version 7.00. RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer Corp., Elkhart, IN, by telephone and fax on January 21, 2002. Manufacturer: Bayer Corporation, Mishawaka, IN. Firm initiated recall is...Read More

Company: Abbott Laboratories, Inc Date of Enforcement Report: 3/24/02 Class: II PRODUCT AEROSET System Software v1.00ER005.2 and v1.0ER005 Catalog Numbers: 2-8996-02 and 2-89996-01. Recall # Z-0594-2/0595-2. REASON System may incorrectly associate sample ID & test requests undercertain conditions of non-bar coded or unreadable bar coded samples. CODE All Codes are affected by this field correction....Read More

Company: Sunquest Information Systems IncDate of Enforcement Report: 3/6/02 Class: II PRODUCT FlexiLab Laboratory Information System, Version 5.2, 5.23, and 5.3, Recall # Z-0531-02. REASON Software glitch can cause results to be filed under an incorrect accession number under certain conditions. CODE Versions 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems Inc., Tucson, AZ,...Read More

Company: ADAC LaboratoriesDate of Enforcement Report: 2/13/02 Class: II PRODUCT ADAC brand Pinnacle Radiation Therapy Planning System Radiation Therapy Treatment Software version 5.2g, Recall # Z-0524-02. REASON A Software problem that could result in incorrect radiation dosage being applied. CODE Model: 9200-0579A. RECALLING FIRM/MANUFACTURER ADAC Laboratories, Milpitas, CA, by letters on Sept. 26, 2000. Firm...Read More

Company: Sunquest Information Systems, IncDate of Enforcement Report: 2/13/02 Class: II PRODUCT FlexiLab? Laboratory Information System, Recall # B-0710-2. REASON Blood bank computer system, which had a software glitch or defect, was distributed. CODE Versions 5.23 and 5.3 with RBR module. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter dated March 19, 2001....Read More

Company: Sunquest Information Systems, Inc Date of Enforcement Report: 2/13/02 Class: II PRODUCT FlexiLab? Blood Bank and Blood Donor Software, Recall # B-0711-2. REASON Blood bank computer system, which had a software glitch or defect, was distributed. CODE Versions 5.2 and 5.23. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter dated June 22,...Read More

Company: Sunquest Information Systems, IncDate of Enforcement Report: 2/13/2002 Class: II PRODUCT FlexiLab? Blood Bank and Blood Donor Software, Recall # B-0709-2. REASON Blood bank computer system, which had a software glitch or defect, was distributed. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter dated March 13,...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 2/6/02 Class: II PRODUCT All DataCare Systems Software, as follows: A) DataCare Server/Workstation Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200. Sold in the U.S. B) DataCare Networked Client Computer for DataCare ABG Data Management System...Read More

Company: Mediware Information Systems, IncDate of Enforcement Report: 2/30/02 Class: III PRODUCT Hemocare Blood Bank Data Management System Software, Recall # B-0626-2. REASON Computer software that could allow the assignment of an extended expiration date to blood products was distributed. CODE Versions 5.1, 5.2, 5.2a, and 5.2b. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY...Read More

Company: Dade Behring, IncDate of Enforcement Report: 1/30/02 Class: II PRODUCT Dimension Clinical Chemical Analyzer XL/RxL/ARx with software revision 5.2, Recall # Z-0433-02. REASON Instructions to software revision are missing a step. CODE Revision 5.2 The following serial numbers are involved in the recall: 971807, 973002, 970457, 973278, 970598, 970454, 970049, 971979, 973242, 970864, 973218,...Read More

Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0670-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0668-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: 111 PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0671-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Mediware Information Systems, Inc.Date of Enforcement Report: 1/23/02 Class: III PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0669-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Mediware Information Systems, Inc.Date of Enforcement Report: 1/23/02 Class: III PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0667-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: III PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0666-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Sunquest Information Systems, IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT FlexiLab? Blood Bank and Blood Donor Software (3 versions), Recall # B-0627-2. REASON Blood establishment computer software that could allow the release of unsuitable blood products was distributed. CODE Version numbers 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ,...Read More

Company: Biochem Immunosystems (U.S.), IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT Personal Lab Version 2.2a. The device is an Immunochemistry Analyzer Open System, Recall # Z-0463-02. REASON Samples were not picked up and added to the dilution tube. CODE Version 2.2a Catalog # PL01. RECALLING FIRM/MANUFACTURER Recalling Firm: Biochem Immunosystems (U.S.), Inc. Allentown, PA,...Read More

Company: Siemens Medical Systems, INCDate of Enforcement Report: 11/16/01 Class: III PRODUCT Autoperfusion Software, which includes The Cardiac Review (Profile Review) application, used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies. Recall # Z-0428-02. REASON...Read More

Company: Siemens Medical Systems, IncDate of Enforcement Report: 1/16/02 Class: III PRODUCT Autoperfusion Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies. Recall # Z-0427-02. REASON The software did not save oblique data correctly...Read More

Company: Multidata Systems International Corp.Date of Enforcement Report: 11/28/01 Class: II PRODUCT Radiation Treatment Planning Decision Support System (DSS), Recall # Z-0213-2. REASON The software calculates radiation overdoses that require human intervention to detect and prevent injury to radiation therapy patients. CODE All versions. RECALLING FIRM/MANUFACTURER Multidata Systems International Corp., St. Louis, MO, by letter...Read More

Company: Abbott Laboratories, IncDate of Enforcement Report: 11/28/01 Class: II PRODUCT The Abbott AxSYM System is a fully automated Immunoassay analyzer designed to perform Microparticle Enzyme Immunoassay (MEIA), Fluorescence Polarization Immunoassay (FPIA), Radiative Energy Attenuation (REA) Assay Technology, and Ion Capture (IC) Immunoassay Technologies. The AxSYM System performs random access, continuous access, and STAT processing...Read More

Company: Radionics, A Division of Tyco HealthcareDate of Enforcement Report: 11/21/01 Class: II PRODUCT Radionics XKnife RT Software, Recall # Z-0275-2. REASON Software error may cause incorrect jaw settings for a record/verify system. CODE Version 1.02 and lower. RECALLING FIRM/ MANFACTURER Radionics, A Division of Tyco Healthcare, Billerica, MA, by telephonebetween 9/17/2001 and 18/01. Firm...Read More

Company: Novametrix Medical Systems, IncDate of Enforcement Report: 11/7/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0216-2, Novametrix NICO Monitor, Model 7300 with software versions below 4.3 REASON: Monitor may miscalculate Pulse Rate and Oxygen Saturation (SpO2) values. MANUFACTURER/RECALLING FIRM: Novametrix Medical Systems, Inc., Wallingford, CT RECALLED BY: Recalling firm by letter on 7/9/01 FIRM...Read More

Company: Marconi Medical Systems, IncClass: II Date of Enforcement Report: 10/31/01 RECALL NUMBER, PRODUCT AND CODE: Z-0181-2, Marconi MX8000 Computed Tomography X-ray System, Codes: All Marconi MX8000 CT Scanners, running with Version 2.0 and 2.01 software. REASON: Software in version 2.0 / 2.01 software may lead to improper patient treatment. MANUFACTURER/RECALLING FIRM: Marconi Medical Systems,...Read More

Company: Nihon Kohden, IncDate of Enforcement Report: 10/24/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0177-2/Z-0178-2, Procyon Bedside Monitors, Models BSM-4104A and BSM- 4114A. Codes: Models BSM-4104A and BSM-4114A Bedside Monitors. REASON: Software causes infusion rate 2.2 times proper rate. MANUFACTURER/RECALLING FIRM: Nihon Kohden, Inc., CA RECALLED BY: Recalling firm by telephone and letter on...Read More